PHILADELPHIA – When a very low birth weight (VLWBW) infant has congenital heart disease needing surgical repair, the two opposing strategies of immediate surgery or delaying surgery for several weeks until the newborn grows larger work equally well for survival. Survival rates after both approaches tracked nearly identically during 3 years of follow-up, in a single center review of 80 cases.

Because the review included a relatively small number of VLBW newborns, the analysis could not determine which benefited most from immediate surgery and which did better with a delayed operation. "But we were reassured that delay did not lead to excess risk," Dr. Edward J. Hickey said at the annual meeting of the American Association for Thoracic Surgery.

Results from a second, related analysis that he reported showed that birth weight surpassed gestational age as a predictor of survival in newborns with congenital heart disease. "Birth weight is a more reliable, independent risk factor for death," said Dr. Hickey, a cardiothoracic surgeon at the Hospital for Sick Children in Toronto. The analysis showed that the highest risk for survival occurred in newborns who weighed less than 2.0 kg at birth. As a result of this finding, Dr. Hickey’s comparison of immediate and delayed surgical repair focused on the 80 newborns in the series who weighed less than 2.0 kg and required prompt intervention.

Among these 80 infants, 34 had "immediate surgery," which meant they had their operation as soon as it could be scheduled and performed, generally within 3 weeks of birth. Surgery for the other 46 was an average of 8 weeks after birth. These differences reflected the way surgeons at Sick Children managed each case.

Among the delayed surgery cases, infants with truncus or coarctation had the slowest growth, with as little as 50 g gained per week. In contrast, infants with an atrial septal defect, tetralogy, or a total anomalous pulmonary venous connection had growth rates above average, often at a pace of more than 150 g/week.

"I was most struck by the infants with coarctation, who seemed to grow at very low rates. That suggests to us that these patients are the ones we should repair early," because it is less likely that a delay would lead to much weight gain and improved surgical prospects, Dr. Hickey said. Based on these findings, he and his associates now perform coarctation repairs in infants whose weight is as low as 1.4 kg, he said. But Dr. Hickey also stressed that the timing of surgical repair must be individualized for each patient.

The two analyses done by Dr. Hickey and his associates involved 1,557 children with congenital heart disease admitted to the Hospital for Sick Children at age 30 days or younger who underwent active management during a 10-year period. Overall survival in this group was 91% at 3 months after admission, 88% after 6 months, and 86% after 5 years.

They evaluated the impact of both gestational age and birth weight on survival among these children, and found that both parameters were linked to mortality. Infants born at 28 weeks’ gestational age had a roughly 40% survival rate after 1 year, those born at 32 weeks had about a 60% survival rate to 1 year, and those born at 36 weeks had about an 80% survival rate at 1 year.

When analyzed by birth weight, those born at 3.5 kg or larger had a greater than 90% 1-year survival rate, those born with a weight of 2.0 kg had about an 80% 1-year survival, and those born weighing 1.5 kg had about a 60% survival to 1 year. These data identified an inflection point where infants born weighing less than 2.0 kg had a substantially worse survival than those who weighed 2.0 kg or more. Additional analysis that compared the relative contributions of gestational age and birth weight also showed that birth weight was the much stronger factor influencing 1-year survival.

The series included 149 infants born at less than 2.0 kg, highlighting how uncommon it is for surgeons to face the question of how to manage VLBW infants with congenital heart disease. Eighty-five of these infants (57%) weighed 1.5-1.9 kg at birth, while the remainder weighed less than 1.5 kg. Thirty did not require immediate surgical intervention, 12 had other, noncardiovascular complications requiring initial intervention, and 27 received comfort care only, leaving 80 candidates that became part of the immediate – versus delayed – surgery analysis.

Among the 46 infants whose surgery was delayed for an average of 8 weeks, 18 (39%) had a total of 33 complications. Six of these 18 children died while awaiting surgery. "Despite this high complication rate, we see roughly equivalent survival" between the immediate and delayed surgery groups. That observation, coupled with the finding that many infants gained weight at an "acceptable" rate during the period of surgical delay, led to the conclusion that either strategy is reasonable and should depend on the specific features of each case, he said.

Dr. Hickey had no disclosures. ☐

PHILADELPHIA – When a very low birth weight (VLWBW) infant has congenital heart disease needing surgical repair, the two opposing strategies of immediate surgery or delaying surgery for several weeks until the newborn grows larger work equally well for survival. Survival rates after both approaches tracked nearly identically during 3 years of follow-up, in a single center review of 80 cases.

Because the review included a relatively small number of VLBW newborns, the analysis could not determine which benefited most from immediate surgery and which did better with a delayed operation. "But we were reassured that delay did not lead to excess risk," Dr. Edward J. Hickey said at the annual meeting of the American Association for Thoracic Surgery.

Results from a second, related analysis that he reported showed that birth weight surpassed gestational age as a predictor of survival in newborns with congenital heart disease. "Birth weight is a more reliable, independent risk factor for death," said Dr. Hickey, a cardiothoracic surgeon at the Hospital for Sick Children in Toronto. The analysis showed that the highest risk for survival occurred in newborns who weighed less than 2.0 kg at birth. As a result of this finding, Dr. Hickey’s comparison of immediate and delayed surgical repair focused on the 80 newborns in the series who weighed less than 2.0 kg and required prompt intervention.

Among these 80 infants, 34 had "immediate surgery," which meant they had their operation as soon as it could be scheduled and performed, generally within 3 weeks of birth. Surgery for the other 46 was an average of 8 weeks after birth. These differences reflected the way surgeons at Sick Children managed each case.

Among the delayed surgery cases, infants with truncus or coarctation had the slowest growth, with as little as 50 g gained per week. In contrast, infants with an atrial septal defect, tetralogy, or a total anomalous pulmonary venous connection had growth rates above average, often at a pace of more than 150 g/week.

"I was most struck by the infants with coarctation, who seemed to grow at very low rates. That suggests to us that these patients are the ones we should repair early," because it is less likely that a delay would lead to much weight gain and improved surgical prospects, Dr. Hickey said. Based on these findings, he and his associates now perform coarctation repairs in infants whose weight is as low as 1.4 kg, he said. But Dr. Hickey also stressed that the timing of surgical repair must be individualized for each patient.

The two analyses done by Dr. Hickey and his associates involved 1,557 children with congenital heart disease admitted to the Hospital for Sick Children at age 30 days or younger who underwent active management during a 10-year period. Overall survival in this group was 91% at 3 months after admission, 88% after 6 months, and 86% after 5 years.

They evaluated the impact of both gestational age and birth weight on survival among these children, and found that both parameters were linked to mortality. Infants born at 28 weeks’ gestational age had a roughly 40% survival rate after 1 year, those born at 32 weeks had about a 60% survival rate to 1 year, and those born at 36 weeks had about an 80% survival rate at 1 year.

When analyzed by birth weight, those born at 3.5 kg or larger had a greater than 90% 1-year survival rate, those born with a weight of 2.0 kg had about an 80% 1-year survival, and those born weighing 1.5 kg had about a 60% survival to 1 year. These data identified an inflection point where infants born weighing less than 2.0 kg had a substantially worse survival than those who weighed 2.0 kg or more. Additional analysis that compared the relative contributions of gestational age and birth weight also showed that birth weight was the much stronger factor influencing 1-year survival.

The series included 149 infants born at less than 2.0 kg, highlighting how uncommon it is for surgeons to face the question of how to manage VLBW infants with congenital heart disease. Eighty-five of these infants (57%) weighed 1.5-1.9 kg at birth, while the remainder weighed less than 1.5 kg. Thirty did not require immediate surgical intervention, 12 had other, noncardiovascular complications requiring initial intervention, and 27 received comfort care only, leaving 80 candidates that became part of the immediate – versus delayed – surgery analysis.

Among the 46 infants whose surgery was delayed for an average of 8 weeks, 18 (39%) had a total of 33 complications. Six of these 18 children died while awaiting surgery. "Despite this high complication rate, we see roughly equivalent survival" between the immediate and delayed surgery groups. That observation, coupled with the finding that many infants gained weight at an "acceptable" rate during the period of surgical delay, led to the conclusion that either strategy is reasonable and should depend on the specific features of each case, he said.

Dr. Hickey had no disclosures. ☐

PHILADELPHIA – When a very low birth weight (VLWBW) infant has congenital heart disease needing surgical repair, the two opposing strategies of immediate surgery or delaying surgery for several weeks until the newborn grows larger work equally well for survival. Survival rates after both approaches tracked nearly identically during 3 years of follow-up, in a single center review of 80 cases.

Because the review included a relatively small number of VLBW newborns, the analysis could not determine which benefited most from immediate surgery and which did better with a delayed operation. "But we were reassured that delay did not lead to excess risk," Dr. Edward J. Hickey said at the annual meeting of the American Association for Thoracic Surgery.

Results from a second, related analysis that he reported showed that birth weight surpassed gestational age as a predictor of survival in newborns with congenital heart disease. "Birth weight is a more reliable, independent risk factor for death," said Dr. Hickey, a cardiothoracic surgeon at the Hospital for Sick Children in Toronto. The analysis showed that the highest risk for survival occurred in newborns who weighed less than 2.0 kg at birth. As a result of this finding, Dr. Hickey’s comparison of immediate and delayed surgical repair focused on the 80 newborns in the series who weighed less than 2.0 kg and required prompt intervention.

Among these 80 infants, 34 had "immediate surgery," which meant they had their operation as soon as it could be scheduled and performed, generally within 3 weeks of birth. Surgery for the other 46 was an average of 8 weeks after birth. These differences reflected the way surgeons at Sick Children managed each case.

Among the delayed surgery cases, infants with truncus or coarctation had the slowest growth, with as little as 50 g gained per week. In contrast, infants with an atrial septal defect, tetralogy, or a total anomalous pulmonary venous connection had growth rates above average, often at a pace of more than 150 g/week.

"I was most struck by the infants with coarctation, who seemed to grow at very low rates. That suggests to us that these patients are the ones we should repair early," because it is less likely that a delay would lead to much weight gain and improved surgical prospects, Dr. Hickey said. Based on these findings, he and his associates now perform coarctation repairs in infants whose weight is as low as 1.4 kg, he said. But Dr. Hickey also stressed that the timing of surgical repair must be individualized for each patient.

The two analyses done by Dr. Hickey and his associates involved 1,557 children with congenital heart disease admitted to the Hospital for Sick Children at age 30 days or younger who underwent active management during a 10-year period. Overall survival in this group was 91% at 3 months after admission, 88% after 6 months, and 86% after 5 years.

They evaluated the impact of both gestational age and birth weight on survival among these children, and found that both parameters were linked to mortality. Infants born at 28 weeks’ gestational age had a roughly 40% survival rate after 1 year, those born at 32 weeks had about a 60% survival rate to 1 year, and those born at 36 weeks had about an 80% survival rate at 1 year.

When analyzed by birth weight, those born at 3.5 kg or larger had a greater than 90% 1-year survival rate, those born with a weight of 2.0 kg had about an 80% 1-year survival, and those born weighing 1.5 kg had about a 60% survival to 1 year. These data identified an inflection point where infants born weighing less than 2.0 kg had a substantially worse survival than those who weighed 2.0 kg or more. Additional analysis that compared the relative contributions of gestational age and birth weight also showed that birth weight was the much stronger factor influencing 1-year survival.

The series included 149 infants born at less than 2.0 kg, highlighting how uncommon it is for surgeons to face the question of how to manage VLBW infants with congenital heart disease. Eighty-five of these infants (57%) weighed 1.5-1.9 kg at birth, while the remainder weighed less than 1.5 kg. Thirty did not require immediate surgical intervention, 12 had other, noncardiovascular complications requiring initial intervention, and 27 received comfort care only, leaving 80 candidates that became part of the immediate – versus delayed – surgery analysis.

Among the 46 infants whose surgery was delayed for an average of 8 weeks, 18 (39%) had a total of 33 complications. Six of these 18 children died while awaiting surgery. "Despite this high complication rate, we see roughly equivalent survival" between the immediate and delayed surgery groups. That observation, coupled with the finding that many infants gained weight at an "acceptable" rate during the period of surgical delay, led to the conclusion that either strategy is reasonable and should depend on the specific features of each case, he said.

Dr. Hickey had no disclosures. ☐

The Food and Drug Administration on Oct. 7 announced the approval of a combination pill containing fixed doses of sitagliptin and simvastatin for people in whom treatment with both drugs is indicated.

The combination product, which will be marketed as Juvisync, is the first product that combines in a single tablet a drug approved for treating type 2 diabetes with a cholesterol-lowering drug, according to an agency statement announcing the approval.

Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes; it is marketed as Januvia (and as Janumet in combination with metformin). Simvastatin is an HMG-CoA reductase inhibitor approved for use with diet and exercise to lower low-density lipoprotein cholesterol and is marketed as Zocor and is available in generic formulations (and in combination with niacin and with ezetimibe).

Approval of Juvisync is based on the "substantial experience" with both drugs separately, "and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately," according to the statement, which describes Juvisync as a "convenience combination" that should only be prescribed "when it is appropriate for a patient to be placed on both of these drugs."

"To ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients," Dr. Mary H. Parks, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research said in the statement.

The approved dosage strengths of the sitagliptin/simvastatin combination are 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg, all of which are taken as a single dose in the evening, according to the prescribing information.

The manufacturer has committed to developing combined tablets containing the 50 mg sitagliptin dose, with 10 mg, 20 mg and 40 mg of simvastatin, but until these are available, patients who need the 50-mg dose of sitagliptin should be prescribed the single-ingredient tablet. There are no plans to develop a combination tablet with the 25-mg sitagliptin dose, which is not used very much, or with the 80-mg dose of simvastatin, because of recent restrictions on the use of this dose because it is associated with an increased risk of muscle toxicity, the statement said.

The statement says that the agency has recently become aware of the potential for statins to increase serum glucose levels in patients with type 2 diabetes, although the risk "appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes." To assess this risk further, the FDA is requiring that the manufacturer conduct a postmarketing clinical study. The FDA’s approval letter for Juvisync says that the trial should be a randomized, double-blind, active-controlled study that compares the effect of sitagliptin and simvastatin fixed-dose combination with sitagliptin on glycemic control in type 2 diabetic patients on background metformin therapy.

Juvisync is manufactured by MSD International GmbH Clonmel Co., based in Tipperary, Ireland.

The Food and Drug Administration on Oct. 7 announced the approval of a combination pill containing fixed doses of sitagliptin and simvastatin for people in whom treatment with both drugs is indicated.

The combination product, which will be marketed as Juvisync, is the first product that combines in a single tablet a drug approved for treating type 2 diabetes with a cholesterol-lowering drug, according to an agency statement announcing the approval.

Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes; it is marketed as Januvia (and as Janumet in combination with metformin). Simvastatin is an HMG-CoA reductase inhibitor approved for use with diet and exercise to lower low-density lipoprotein cholesterol and is marketed as Zocor and is available in generic formulations (and in combination with niacin and with ezetimibe).

Approval of Juvisync is based on the "substantial experience" with both drugs separately, "and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately," according to the statement, which describes Juvisync as a "convenience combination" that should only be prescribed "when it is appropriate for a patient to be placed on both of these drugs."

"To ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients," Dr. Mary H. Parks, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research said in the statement.

The approved dosage strengths of the sitagliptin/simvastatin combination are 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg, all of which are taken as a single dose in the evening, according to the prescribing information.

The manufacturer has committed to developing combined tablets containing the 50 mg sitagliptin dose, with 10 mg, 20 mg and 40 mg of simvastatin, but until these are available, patients who need the 50-mg dose of sitagliptin should be prescribed the single-ingredient tablet. There are no plans to develop a combination tablet with the 25-mg sitagliptin dose, which is not used very much, or with the 80-mg dose of simvastatin, because of recent restrictions on the use of this dose because it is associated with an increased risk of muscle toxicity, the statement said.

The statement says that the agency has recently become aware of the potential for statins to increase serum glucose levels in patients with type 2 diabetes, although the risk "appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes." To assess this risk further, the FDA is requiring that the manufacturer conduct a postmarketing clinical study. The FDA’s approval letter for Juvisync says that the trial should be a randomized, double-blind, active-controlled study that compares the effect of sitagliptin and simvastatin fixed-dose combination with sitagliptin on glycemic control in type 2 diabetic patients on background metformin therapy.

Juvisync is manufactured by MSD International GmbH Clonmel Co., based in Tipperary, Ireland.

The Food and Drug Administration on Oct. 7 announced the approval of a combination pill containing fixed doses of sitagliptin and simvastatin for people in whom treatment with both drugs is indicated.

The combination product, which will be marketed as Juvisync, is the first product that combines in a single tablet a drug approved for treating type 2 diabetes with a cholesterol-lowering drug, according to an agency statement announcing the approval.

Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes; it is marketed as Januvia (and as Janumet in combination with metformin). Simvastatin is an HMG-CoA reductase inhibitor approved for use with diet and exercise to lower low-density lipoprotein cholesterol and is marketed as Zocor and is available in generic formulations (and in combination with niacin and with ezetimibe).

Approval of Juvisync is based on the "substantial experience" with both drugs separately, "and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately," according to the statement, which describes Juvisync as a "convenience combination" that should only be prescribed "when it is appropriate for a patient to be placed on both of these drugs."

"To ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients," Dr. Mary H. Parks, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research said in the statement.

The approved dosage strengths of the sitagliptin/simvastatin combination are 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg, all of which are taken as a single dose in the evening, according to the prescribing information.

The manufacturer has committed to developing combined tablets containing the 50 mg sitagliptin dose, with 10 mg, 20 mg and 40 mg of simvastatin, but until these are available, patients who need the 50-mg dose of sitagliptin should be prescribed the single-ingredient tablet. There are no plans to develop a combination tablet with the 25-mg sitagliptin dose, which is not used very much, or with the 80-mg dose of simvastatin, because of recent restrictions on the use of this dose because it is associated with an increased risk of muscle toxicity, the statement said.

The statement says that the agency has recently become aware of the potential for statins to increase serum glucose levels in patients with type 2 diabetes, although the risk "appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes." To assess this risk further, the FDA is requiring that the manufacturer conduct a postmarketing clinical study. The FDA’s approval letter for Juvisync says that the trial should be a randomized, double-blind, active-controlled study that compares the effect of sitagliptin and simvastatin fixed-dose combination with sitagliptin on glycemic control in type 2 diabetic patients on background metformin therapy.

Juvisync is manufactured by MSD International GmbH Clonmel Co., based in Tipperary, Ireland.

LISBON – Even small changes in hemoglobin A_1c and blood pressure could significantly reduce the risk of heart attack, stroke, and other cardiovascular complications in people with type 2 diabetes, according to the findings of a population-based observational study.

A 0.5% decrease in HbA_1c and a 10 Hg/mm decrease in systolic blood pressure could avert 10% of such events over 5 years, Dr. Edith Heintjes said at the annual meeting of the European Society for the Study of Diabetes. Greater changes could reduce cardiovascular events by as much as 21%, said Dr. Heintjes of the PHARMO Institute for Drug Research, Utrecht, the Netherlands.

While her study on population attributable risk was albeit theoretical, it still adds weight to the emerging theory that small changes can make a big difference to the health of people with type 2 diabetes.

"Even when we examined only modest incremental reductions, which could be achieved in the clinical setting, we found the possibility of significant benefit," she said. Those patients with the greatest risk factors – elevated HbA_1c, high blood pressure, and higher body mass index – stand to gain the most when they improve those factors, she said.

Dr. Heintjes’ analysis included 5,841 Dutch patients with a diagnosis of type 2 diabetes for at least 2 years. The patients were all taking some form of treatment – oral medications, insulin, or both – for at least 6 months to be included in the study. After examining both baseline data and 5-year outcomes, she was able to extrapolate how improvements in the three risk factors might impact the expected number of cardiovascular events.

Patient data were drawn from the PHARMO record linkage system, which includes community pharmaceutical dispensing information, laboratory information, national hospitalization information, and statistics from the Dutch national diabetes monitoring program.

Patients were treated with the aim of achieving the country’s national targets: an HbA_1c of below 7%, a systolic blood pressure of 140 mmHg or lower, and a body mass index of 25 kg/m² or less.

"Even when we examined only modest incremental reductions, we found the possibility of significant benefit."

At baseline, the patients’ average age was 66 years. The average HbA_1c was 7%; systolic blood pressure 149 mmHg, and body mass index, 29.5 kg/m². Most (92%) were taking only oral medications; the remainder was also taking insulin.

Some cardiovascular morbidity was already present in the group, including peripheral artery disease (0.5%), renal impairment (11%), neuropathy (51%), and retinopathy (7%). About half of the group (45%) had a family history of cardiovascular disease.

Dr. Heintjes divided the group according to the number of risk factors each patient exhibited. A quarter (24%) had just one elevated risk factor; 47% had two elevated risk factors, and 26% had elevations in all three risk factors.

A multivariable analysis allowed her to extrapolate that 796 cardiovascular events (heart attack, ischemic heart disease, stroke, and chronic heart failure) would occur if all of the patients were followed for 5 years.

If every patient in this population were able to correct each one of the risk factors to the national recommendations, she said, 687 events would occur – a 14% decrease. Correcting HbA_1c and blood pressure accounted for this change, she said; changing BMI did nothing to increase the benefit.

Theoretically, she said, patients with the most risk factors would reap the greatest benefit. The 24% with one elevated risk factor would experience a 5% reduction in cardiovascular events, while those with all three elevated risk factors, upon correcting them, would see a 21% reduction.

Considering the group’s baseline measurements, correcting to national Dutch standards would mean an average HbA_1c reduction of 0.8%, a 26-mmHg reduction in systolic blood pressure, and a weight loss of 16 kg (equivalent to a BMI decrease of 5.7 kg/m²). However, Dr. Heintjes said, it might not be realistic to expect such changes. Her second analysis explored the improvements that could arise from smaller changes: a 0.5% reduction in HbA_1c, a 10-mmHg reduction in systolic blood pressure and a 10% reduction in total body weight (2.6 kg/m² decrease in BMI).

"With this analysis, we saw in the overall population that 6% of the risk could be averted," she said. Among those in the subpopulation with three risk factors, applying the smaller changes could cut the number of events by 10%.

It’s not exactly clear how the results can change clinical practice, Dr. Heintjes acknowledged. "But this does allow us to understand how small changes can translate into bigger benefits for people with type 2 diabetes."

Dr. Heintjes reported having no conflicts of interest. Her employer, PHARMO, however, receives funding from numerous pharmaceutical companies, including Astra Zeneca, which sponsored the current study.

LISBON – Even small changes in hemoglobin A_1c and blood pressure could significantly reduce the risk of heart attack, stroke, and other cardiovascular complications in people with type 2 diabetes, according to the findings of a population-based observational study.

A 0.5% decrease in HbA_1c and a 10 Hg/mm decrease in systolic blood pressure could avert 10% of such events over 5 years, Dr. Edith Heintjes said at the annual meeting of the European Society for the Study of Diabetes. Greater changes could reduce cardiovascular events by as much as 21%, said Dr. Heintjes of the PHARMO Institute for Drug Research, Utrecht, the Netherlands.

While her study on population attributable risk was albeit theoretical, it still adds weight to the emerging theory that small changes can make a big difference to the health of people with type 2 diabetes.

"Even when we examined only modest incremental reductions, which could be achieved in the clinical setting, we found the possibility of significant benefit," she said. Those patients with the greatest risk factors – elevated HbA_1c, high blood pressure, and higher body mass index – stand to gain the most when they improve those factors, she said.

Dr. Heintjes’ analysis included 5,841 Dutch patients with a diagnosis of type 2 diabetes for at least 2 years. The patients were all taking some form of treatment – oral medications, insulin, or both – for at least 6 months to be included in the study. After examining both baseline data and 5-year outcomes, she was able to extrapolate how improvements in the three risk factors might impact the expected number of cardiovascular events.

Patient data were drawn from the PHARMO record linkage system, which includes community pharmaceutical dispensing information, laboratory information, national hospitalization information, and statistics from the Dutch national diabetes monitoring program.

Patients were treated with the aim of achieving the country’s national targets: an HbA_1c of below 7%, a systolic blood pressure of 140 mmHg or lower, and a body mass index of 25 kg/m² or less.

"Even when we examined only modest incremental reductions, we found the possibility of significant benefit."

At baseline, the patients’ average age was 66 years. The average HbA_1c was 7%; systolic blood pressure 149 mmHg, and body mass index, 29.5 kg/m². Most (92%) were taking only oral medications; the remainder was also taking insulin.

Some cardiovascular morbidity was already present in the group, including peripheral artery disease (0.5%), renal impairment (11%), neuropathy (51%), and retinopathy (7%). About half of the group (45%) had a family history of cardiovascular disease.

Dr. Heintjes divided the group according to the number of risk factors each patient exhibited. A quarter (24%) had just one elevated risk factor; 47% had two elevated risk factors, and 26% had elevations in all three risk factors.

A multivariable analysis allowed her to extrapolate that 796 cardiovascular events (heart attack, ischemic heart disease, stroke, and chronic heart failure) would occur if all of the patients were followed for 5 years.

If every patient in this population were able to correct each one of the risk factors to the national recommendations, she said, 687 events would occur – a 14% decrease. Correcting HbA_1c and blood pressure accounted for this change, she said; changing BMI did nothing to increase the benefit.

Theoretically, she said, patients with the most risk factors would reap the greatest benefit. The 24% with one elevated risk factor would experience a 5% reduction in cardiovascular events, while those with all three elevated risk factors, upon correcting them, would see a 21% reduction.

Considering the group’s baseline measurements, correcting to national Dutch standards would mean an average HbA_1c reduction of 0.8%, a 26-mmHg reduction in systolic blood pressure, and a weight loss of 16 kg (equivalent to a BMI decrease of 5.7 kg/m²). However, Dr. Heintjes said, it might not be realistic to expect such changes. Her second analysis explored the improvements that could arise from smaller changes: a 0.5% reduction in HbA_1c, a 10-mmHg reduction in systolic blood pressure and a 10% reduction in total body weight (2.6 kg/m² decrease in BMI).

"With this analysis, we saw in the overall population that 6% of the risk could be averted," she said. Among those in the subpopulation with three risk factors, applying the smaller changes could cut the number of events by 10%.

It’s not exactly clear how the results can change clinical practice, Dr. Heintjes acknowledged. "But this does allow us to understand how small changes can translate into bigger benefits for people with type 2 diabetes."

Dr. Heintjes reported having no conflicts of interest. Her employer, PHARMO, however, receives funding from numerous pharmaceutical companies, including Astra Zeneca, which sponsored the current study.

LISBON – Even small changes in hemoglobin A_1c and blood pressure could significantly reduce the risk of heart attack, stroke, and other cardiovascular complications in people with type 2 diabetes, according to the findings of a population-based observational study.

A 0.5% decrease in HbA_1c and a 10 Hg/mm decrease in systolic blood pressure could avert 10% of such events over 5 years, Dr. Edith Heintjes said at the annual meeting of the European Society for the Study of Diabetes. Greater changes could reduce cardiovascular events by as much as 21%, said Dr. Heintjes of the PHARMO Institute for Drug Research, Utrecht, the Netherlands.

While her study on population attributable risk was albeit theoretical, it still adds weight to the emerging theory that small changes can make a big difference to the health of people with type 2 diabetes.

"Even when we examined only modest incremental reductions, which could be achieved in the clinical setting, we found the possibility of significant benefit," she said. Those patients with the greatest risk factors – elevated HbA_1c, high blood pressure, and higher body mass index – stand to gain the most when they improve those factors, she said.

Dr. Heintjes’ analysis included 5,841 Dutch patients with a diagnosis of type 2 diabetes for at least 2 years. The patients were all taking some form of treatment – oral medications, insulin, or both – for at least 6 months to be included in the study. After examining both baseline data and 5-year outcomes, she was able to extrapolate how improvements in the three risk factors might impact the expected number of cardiovascular events.

Patient data were drawn from the PHARMO record linkage system, which includes community pharmaceutical dispensing information, laboratory information, national hospitalization information, and statistics from the Dutch national diabetes monitoring program.

Patients were treated with the aim of achieving the country’s national targets: an HbA_1c of below 7%, a systolic blood pressure of 140 mmHg or lower, and a body mass index of 25 kg/m² or less.

"Even when we examined only modest incremental reductions, we found the possibility of significant benefit."

At baseline, the patients’ average age was 66 years. The average HbA_1c was 7%; systolic blood pressure 149 mmHg, and body mass index, 29.5 kg/m². Most (92%) were taking only oral medications; the remainder was also taking insulin.

Some cardiovascular morbidity was already present in the group, including peripheral artery disease (0.5%), renal impairment (11%), neuropathy (51%), and retinopathy (7%). About half of the group (45%) had a family history of cardiovascular disease.

Dr. Heintjes divided the group according to the number of risk factors each patient exhibited. A quarter (24%) had just one elevated risk factor; 47% had two elevated risk factors, and 26% had elevations in all three risk factors.

A multivariable analysis allowed her to extrapolate that 796 cardiovascular events (heart attack, ischemic heart disease, stroke, and chronic heart failure) would occur if all of the patients were followed for 5 years.

If every patient in this population were able to correct each one of the risk factors to the national recommendations, she said, 687 events would occur – a 14% decrease. Correcting HbA_1c and blood pressure accounted for this change, she said; changing BMI did nothing to increase the benefit.

Theoretically, she said, patients with the most risk factors would reap the greatest benefit. The 24% with one elevated risk factor would experience a 5% reduction in cardiovascular events, while those with all three elevated risk factors, upon correcting them, would see a 21% reduction.

Considering the group’s baseline measurements, correcting to national Dutch standards would mean an average HbA_1c reduction of 0.8%, a 26-mmHg reduction in systolic blood pressure, and a weight loss of 16 kg (equivalent to a BMI decrease of 5.7 kg/m²). However, Dr. Heintjes said, it might not be realistic to expect such changes. Her second analysis explored the improvements that could arise from smaller changes: a 0.5% reduction in HbA_1c, a 10-mmHg reduction in systolic blood pressure and a 10% reduction in total body weight (2.6 kg/m² decrease in BMI).

"With this analysis, we saw in the overall population that 6% of the risk could be averted," she said. Among those in the subpopulation with three risk factors, applying the smaller changes could cut the number of events by 10%.

It’s not exactly clear how the results can change clinical practice, Dr. Heintjes acknowledged. "But this does allow us to understand how small changes can translate into bigger benefits for people with type 2 diabetes."

Dr. Heintjes reported having no conflicts of interest. Her employer, PHARMO, however, receives funding from numerous pharmaceutical companies, including Astra Zeneca, which sponsored the current study.

One in 10 hospitalists has worked locum tenens in the past year, according to a study of the practice released this week.

Locum Leaders, a locum tenens staffing agency in Alpharetta, Ga., put the study together this summer to define for the first time just how prevalent the practice of temporary staffing is and what motivates physicians to do the work. The report found that of hospitalists who work as locums tenens, 82% do it in addition to their full-time jobs and 11% do it as their full-time jobs.

Robert Harrington Jr., MD, SFHM, chief medical officer for Locum Leaders and an SHM board member, says the phenomenon allows some hospitalists to learn more about an institution before signing a long-term contract. It also affords other physicians flexibility, higher earning potential, or just the chance to "try something on for size before they buy."

"On the physician side, there are opportunities out there for you to not strain yourself immensely to increase your compensation, to travel to places you may not normally get to go, and to see how different programs are structured and operate," he says. "To see a more worldly view of hospital medicine."

For hospitals, even though locum physicians can cost more in salary, they can provide an opportunity for savings, as the hospital does not have to contribute to healthcare, pensions, or other costs. To wit, locum physicians can gross 30% to 40% more per year for the same number of shifts as a typical FTE hospitalist.

"They're all independent contractors," Dr. Harrington adds. "The increase in compensation that locum tenens physicians are able to demand, for the most part, comes from the difference between having a full-time employee versus an independent contractor."

One in 10 hospitalists has worked locum tenens in the past year, according to a study of the practice released this week.

Locum Leaders, a locum tenens staffing agency in Alpharetta, Ga., put the study together this summer to define for the first time just how prevalent the practice of temporary staffing is and what motivates physicians to do the work. The report found that of hospitalists who work as locums tenens, 82% do it in addition to their full-time jobs and 11% do it as their full-time jobs.

Robert Harrington Jr., MD, SFHM, chief medical officer for Locum Leaders and an SHM board member, says the phenomenon allows some hospitalists to learn more about an institution before signing a long-term contract. It also affords other physicians flexibility, higher earning potential, or just the chance to "try something on for size before they buy."

"On the physician side, there are opportunities out there for you to not strain yourself immensely to increase your compensation, to travel to places you may not normally get to go, and to see how different programs are structured and operate," he says. "To see a more worldly view of hospital medicine."

For hospitals, even though locum physicians can cost more in salary, they can provide an opportunity for savings, as the hospital does not have to contribute to healthcare, pensions, or other costs. To wit, locum physicians can gross 30% to 40% more per year for the same number of shifts as a typical FTE hospitalist.

"They're all independent contractors," Dr. Harrington adds. "The increase in compensation that locum tenens physicians are able to demand, for the most part, comes from the difference between having a full-time employee versus an independent contractor."

One in 10 hospitalists has worked locum tenens in the past year, according to a study of the practice released this week.

Locum Leaders, a locum tenens staffing agency in Alpharetta, Ga., put the study together this summer to define for the first time just how prevalent the practice of temporary staffing is and what motivates physicians to do the work. The report found that of hospitalists who work as locums tenens, 82% do it in addition to their full-time jobs and 11% do it as their full-time jobs.

Robert Harrington Jr., MD, SFHM, chief medical officer for Locum Leaders and an SHM board member, says the phenomenon allows some hospitalists to learn more about an institution before signing a long-term contract. It also affords other physicians flexibility, higher earning potential, or just the chance to "try something on for size before they buy."

"On the physician side, there are opportunities out there for you to not strain yourself immensely to increase your compensation, to travel to places you may not normally get to go, and to see how different programs are structured and operate," he says. "To see a more worldly view of hospital medicine."

For hospitals, even though locum physicians can cost more in salary, they can provide an opportunity for savings, as the hospital does not have to contribute to healthcare, pensions, or other costs. To wit, locum physicians can gross 30% to 40% more per year for the same number of shifts as a typical FTE hospitalist.

"They're all independent contractors," Dr. Harrington adds. "The increase in compensation that locum tenens physicians are able to demand, for the most part, comes from the difference between having a full-time employee versus an independent contractor."

What's the appropriate number of patients that an FTE hospitalist should see in one day? More than half of those surveyed on the-hospitalist.org believe they should see between 11 and 15 patients. According to two members of Team Hospitalist, 10 to 20 patients per day is a reasonable guideline.

"On average, 15 to 18 patients per day is a pretty easy-to-manage number," says Rachel George, MD, MBA, FHM, CPE, chief operating officer for Cogent HMG's west and north-central regions. But daily patient census depends on several factors, such as the types of patients admitted, the length of the doctor's shift, and the level of support from other staff on duty, she explains.

Readers were given one of five choices to respond with: "10 or fewer patients," "11-15," "16-20," "21-25," and "more than 25." Of the 421 responses, 51% felt that the average full-time hospitalist should see from 11 to 15 patients per day, followed by 35% who say they'd prefer to see 16 to 20 patients. Six percent voted for "10 or fewer." Only 4% of respondents said 20 or more patients a day was optimum.

"Honestly, I try not to get fixated on numbers," says Ken Simone, DO, SFHM, founder and president of Hospitalist and Practice Solutions in Veazie, Maine. As a consultant, he says that rather than trying to expect physicians to attend to a standard census, HM groups should focus on acuity of illness and quality of care, and let patient needs dictate the staff required. Dr. Simone also recalled working with some groups who have delegated one or more staff members to handle admitting and screening, so that hospitalists can concentrate on the patients already in beds.

What's the appropriate number of patients that an FTE hospitalist should see in one day? More than half of those surveyed on the-hospitalist.org believe they should see between 11 and 15 patients. According to two members of Team Hospitalist, 10 to 20 patients per day is a reasonable guideline.

"On average, 15 to 18 patients per day is a pretty easy-to-manage number," says Rachel George, MD, MBA, FHM, CPE, chief operating officer for Cogent HMG's west and north-central regions. But daily patient census depends on several factors, such as the types of patients admitted, the length of the doctor's shift, and the level of support from other staff on duty, she explains.

Readers were given one of five choices to respond with: "10 or fewer patients," "11-15," "16-20," "21-25," and "more than 25." Of the 421 responses, 51% felt that the average full-time hospitalist should see from 11 to 15 patients per day, followed by 35% who say they'd prefer to see 16 to 20 patients. Six percent voted for "10 or fewer." Only 4% of respondents said 20 or more patients a day was optimum.

"Honestly, I try not to get fixated on numbers," says Ken Simone, DO, SFHM, founder and president of Hospitalist and Practice Solutions in Veazie, Maine. As a consultant, he says that rather than trying to expect physicians to attend to a standard census, HM groups should focus on acuity of illness and quality of care, and let patient needs dictate the staff required. Dr. Simone also recalled working with some groups who have delegated one or more staff members to handle admitting and screening, so that hospitalists can concentrate on the patients already in beds.

What's the appropriate number of patients that an FTE hospitalist should see in one day? More than half of those surveyed on the-hospitalist.org believe they should see between 11 and 15 patients. According to two members of Team Hospitalist, 10 to 20 patients per day is a reasonable guideline.

"On average, 15 to 18 patients per day is a pretty easy-to-manage number," says Rachel George, MD, MBA, FHM, CPE, chief operating officer for Cogent HMG's west and north-central regions. But daily patient census depends on several factors, such as the types of patients admitted, the length of the doctor's shift, and the level of support from other staff on duty, she explains.

Readers were given one of five choices to respond with: "10 or fewer patients," "11-15," "16-20," "21-25," and "more than 25." Of the 421 responses, 51% felt that the average full-time hospitalist should see from 11 to 15 patients per day, followed by 35% who say they'd prefer to see 16 to 20 patients. Six percent voted for "10 or fewer." Only 4% of respondents said 20 or more patients a day was optimum.

"Honestly, I try not to get fixated on numbers," says Ken Simone, DO, SFHM, founder and president of Hospitalist and Practice Solutions in Veazie, Maine. As a consultant, he says that rather than trying to expect physicians to attend to a standard census, HM groups should focus on acuity of illness and quality of care, and let patient needs dictate the staff required. Dr. Simone also recalled working with some groups who have delegated one or more staff members to handle admitting and screening, so that hospitalists can concentrate on the patients already in beds.

According to a new study in American Economic Journal: Applied Economics by MIT economist Joseph Doyle, a $4,000 increase in per-patient hospital expenditures equates to a 1.4% decrease in mortality rates. Doyle studied 37,000 hospitalized patients in Florida who entered through the ED from 1996 to 2003. However, he focused on those visiting from other states in order to identify variation resulting from the level of care itself, not the prior health of the patients. The greater expense—and benefits—of care in the higher-cost hospital appeared to come from the broader application of ICU tools and greater complement of medical personnel, he notes.

“There are smart ways to spend money and ineffective ways to spend money,” he says, “and we’re still trying to figure out which are which, as much as possible.”

According to a new study in American Economic Journal: Applied Economics by MIT economist Joseph Doyle, a $4,000 increase in per-patient hospital expenditures equates to a 1.4% decrease in mortality rates. Doyle studied 37,000 hospitalized patients in Florida who entered through the ED from 1996 to 2003. However, he focused on those visiting from other states in order to identify variation resulting from the level of care itself, not the prior health of the patients. The greater expense—and benefits—of care in the higher-cost hospital appeared to come from the broader application of ICU tools and greater complement of medical personnel, he notes.

“There are smart ways to spend money and ineffective ways to spend money,” he says, “and we’re still trying to figure out which are which, as much as possible.”

According to a new study in American Economic Journal: Applied Economics by MIT economist Joseph Doyle, a $4,000 increase in per-patient hospital expenditures equates to a 1.4% decrease in mortality rates. Doyle studied 37,000 hospitalized patients in Florida who entered through the ED from 1996 to 2003. However, he focused on those visiting from other states in order to identify variation resulting from the level of care itself, not the prior health of the patients. The greater expense—and benefits—of care in the higher-cost hospital appeared to come from the broader application of ICU tools and greater complement of medical personnel, he notes.

“There are smart ways to spend money and ineffective ways to spend money,” he says, “and we’re still trying to figure out which are which, as much as possible.”

A pilot project that transferred “boarded” patients from one hospital’s ED to an inpatient bed at another nearby hospital in the same health system suggests that the concept could save hospitals millions.

“Improvement in Emergency Department Treatment Capacity: A Health System Integration Approach” was the subject of an oral presentation at HM11 in Dallas. Lead researcher Diego Martinez-Vasquez, MD, MPH, FACP, CPE, medical director for clinical resource utilization at Franklin Square Hospital Center in Baltimore, conducted the research in the University of Maryland medical system.

In the project, 265 patients who consented were transferred 1.3 miles to a sister hospital. Without “boarders”—admitted patients held in the ED—Dr. Martinez-Vasquez’s team found that the referring hospital could have regained enough capacity for an additional 2.9 patients per day. The project also showed median net revenue of $520,000 for the referring hospital and $1.9 million for the accepting hospital.

“The hospitalist group at the receiving hospital was the instrument that facilitated this program,” Dr. Martinez-Vasquez says. “But really what kept my attention was that healthcare systems sometimes don’t use resources effectively. So when I looked at the problem that this particular hospital was having regarding increased boarding time and decreased treatment capacity, I said, ‘Well, one way to resolve this issue is to develop a process that connects two system hospitals and their bed resources.’ ”

A pilot project that transferred “boarded” patients from one hospital’s ED to an inpatient bed at another nearby hospital in the same health system suggests that the concept could save hospitals millions.

“Improvement in Emergency Department Treatment Capacity: A Health System Integration Approach” was the subject of an oral presentation at HM11 in Dallas. Lead researcher Diego Martinez-Vasquez, MD, MPH, FACP, CPE, medical director for clinical resource utilization at Franklin Square Hospital Center in Baltimore, conducted the research in the University of Maryland medical system.

In the project, 265 patients who consented were transferred 1.3 miles to a sister hospital. Without “boarders”—admitted patients held in the ED—Dr. Martinez-Vasquez’s team found that the referring hospital could have regained enough capacity for an additional 2.9 patients per day. The project also showed median net revenue of $520,000 for the referring hospital and $1.9 million for the accepting hospital.

“The hospitalist group at the receiving hospital was the instrument that facilitated this program,” Dr. Martinez-Vasquez says. “But really what kept my attention was that healthcare systems sometimes don’t use resources effectively. So when I looked at the problem that this particular hospital was having regarding increased boarding time and decreased treatment capacity, I said, ‘Well, one way to resolve this issue is to develop a process that connects two system hospitals and their bed resources.’ ”

A pilot project that transferred “boarded” patients from one hospital’s ED to an inpatient bed at another nearby hospital in the same health system suggests that the concept could save hospitals millions.

“Improvement in Emergency Department Treatment Capacity: A Health System Integration Approach” was the subject of an oral presentation at HM11 in Dallas. Lead researcher Diego Martinez-Vasquez, MD, MPH, FACP, CPE, medical director for clinical resource utilization at Franklin Square Hospital Center in Baltimore, conducted the research in the University of Maryland medical system.

In the project, 265 patients who consented were transferred 1.3 miles to a sister hospital. Without “boarders”—admitted patients held in the ED—Dr. Martinez-Vasquez’s team found that the referring hospital could have regained enough capacity for an additional 2.9 patients per day. The project also showed median net revenue of $520,000 for the referring hospital and $1.9 million for the accepting hospital.

“The hospitalist group at the receiving hospital was the instrument that facilitated this program,” Dr. Martinez-Vasquez says. “But really what kept my attention was that healthcare systems sometimes don’t use resources effectively. So when I looked at the problem that this particular hospital was having regarding increased boarding time and decreased treatment capacity, I said, ‘Well, one way to resolve this issue is to develop a process that connects two system hospitals and their bed resources.’ ”

A new study evaluating outcomes for hospitals participating in the American Heart Association’s Get with the Guidelines program found no correlation between high performance on adhering to measures and care standards for acute myocardial infarction and for heart failure despite overlap between the sets of care processes (J Am Coll Cardio. 2011;58:637-644).

A total of 400,000 heart patients were studied, and 283 participating hospitals were stratified into thirds based on their adherence to core quality measures for each disease, with the upper third labeled superior in performance. Lead author Tracy Wang, MD, MHS, MSc, of the Duke Clinical Research Institute in Durham, N.C., and colleagues found that superior performance for only one of the two diseases led to such end-result outcomes as in-hospital mortality that were no better than for hospitals that were not high performers for either condition. But hospitals with superior performance for both conditions had lower in-hospital mortality rates.

“Perhaps quality is more than just following checklists,” Dr. Wang says. “There’s something special about these high-performing hospitals across the board, with better QI, perhaps a little more investment in infrastructure for quality.”

This result, Dr. Wang says, should give ammunition for hospitalists and other physicians to go to their hospital administrators to request more investment in quality improvement overall, not just for specific conditions.

A new study evaluating outcomes for hospitals participating in the American Heart Association’s Get with the Guidelines program found no correlation between high performance on adhering to measures and care standards for acute myocardial infarction and for heart failure despite overlap between the sets of care processes (J Am Coll Cardio. 2011;58:637-644).

A total of 400,000 heart patients were studied, and 283 participating hospitals were stratified into thirds based on their adherence to core quality measures for each disease, with the upper third labeled superior in performance. Lead author Tracy Wang, MD, MHS, MSc, of the Duke Clinical Research Institute in Durham, N.C., and colleagues found that superior performance for only one of the two diseases led to such end-result outcomes as in-hospital mortality that were no better than for hospitals that were not high performers for either condition. But hospitals with superior performance for both conditions had lower in-hospital mortality rates.

“Perhaps quality is more than just following checklists,” Dr. Wang says. “There’s something special about these high-performing hospitals across the board, with better QI, perhaps a little more investment in infrastructure for quality.”

This result, Dr. Wang says, should give ammunition for hospitalists and other physicians to go to their hospital administrators to request more investment in quality improvement overall, not just for specific conditions.

A new study evaluating outcomes for hospitals participating in the American Heart Association’s Get with the Guidelines program found no correlation between high performance on adhering to measures and care standards for acute myocardial infarction and for heart failure despite overlap between the sets of care processes (J Am Coll Cardio. 2011;58:637-644).

A total of 400,000 heart patients were studied, and 283 participating hospitals were stratified into thirds based on their adherence to core quality measures for each disease, with the upper third labeled superior in performance. Lead author Tracy Wang, MD, MHS, MSc, of the Duke Clinical Research Institute in Durham, N.C., and colleagues found that superior performance for only one of the two diseases led to such end-result outcomes as in-hospital mortality that were no better than for hospitals that were not high performers for either condition. But hospitals with superior performance for both conditions had lower in-hospital mortality rates.

“Perhaps quality is more than just following checklists,” Dr. Wang says. “There’s something special about these high-performing hospitals across the board, with better QI, perhaps a little more investment in infrastructure for quality.”

This result, Dr. Wang says, should give ammunition for hospitalists and other physicians to go to their hospital administrators to request more investment in quality improvement overall, not just for specific conditions.

A new Joint Commission program offering advanced certification for hospital-based palliative-care services is accepting applications and conducting daylong surveys through the end of this month. As with the Joint Commission’s reviews of other specialty services (e.g. primary stroke centers), certification is narrower in scope, with service-specific evaluation of care and outcomes, than a full accreditation survey—which is an organizationwide evaluation of core processes and functions.

Advanced certification in palliative care is voluntary for the steadily growing number of acute-care hospitals offering palliative-care services (1,568, according to the latest count by the American Hospital Association), but the hospital seeking it must be accredited by the Joint Commission.1 Certification is intended for formal, defined, inpatient palliative care, whether dedicated units or consultation services, with the ability to direct clinical management of patients.

The core palliative-care team includes “licensed independent practitioners” (typically physicians), registered nurses, chaplains, and social workers.2 The service should follow palliative-care guidelines and evidence-based practice, and it must collect quality data on four performance measures—two of them clinical—and use these data to improve performance.

According to Michelle Sacco, the Joint Commission’s executive director for palliative care, evidence-based practice includes ensuring appropriate transitions to other community resources, such as hospices. She thinks the program is perfect for hospitalists, as HM increasingly is participating in palliative care in their hospitals. “This is also an opportunity to change the mindset that palliative care is for the end-stage only,” Sacco says.

Two-year certification costs $9,655, including the onsite review. For more information, visit the Joint Commission website (www.jointcommission.org/certification) or the Center to Advance Palliative Care’s site (www.capc.org).

References

1. Palliative care in hospitals continues rapid growth for 10th straight year, according to latest analysis. Center to Advance Palliative Care website. Available at: www.capc.org/news-and-events/releases/07-14-11. Accessed Aug. 30, 2011.
2. The National Consensus Project’s Clinical Practice Guidelines for Quality Palliative Care. The National Consensus Project website. Available at: www.nationalconsensusproject.org/. Accessed Aug. 31, 2011.

A new Joint Commission program offering advanced certification for hospital-based palliative-care services is accepting applications and conducting daylong surveys through the end of this month. As with the Joint Commission’s reviews of other specialty services (e.g. primary stroke centers), certification is narrower in scope, with service-specific evaluation of care and outcomes, than a full accreditation survey—which is an organizationwide evaluation of core processes and functions.

Advanced certification in palliative care is voluntary for the steadily growing number of acute-care hospitals offering palliative-care services (1,568, according to the latest count by the American Hospital Association), but the hospital seeking it must be accredited by the Joint Commission.1 Certification is intended for formal, defined, inpatient palliative care, whether dedicated units or consultation services, with the ability to direct clinical management of patients.

The core palliative-care team includes “licensed independent practitioners” (typically physicians), registered nurses, chaplains, and social workers.2 The service should follow palliative-care guidelines and evidence-based practice, and it must collect quality data on four performance measures—two of them clinical—and use these data to improve performance.

According to Michelle Sacco, the Joint Commission’s executive director for palliative care, evidence-based practice includes ensuring appropriate transitions to other community resources, such as hospices. She thinks the program is perfect for hospitalists, as HM increasingly is participating in palliative care in their hospitals. “This is also an opportunity to change the mindset that palliative care is for the end-stage only,” Sacco says.

Two-year certification costs $9,655, including the onsite review. For more information, visit the Joint Commission website (www.jointcommission.org/certification) or the Center to Advance Palliative Care’s site (www.capc.org).

References

1. Palliative care in hospitals continues rapid growth for 10th straight year, according to latest analysis. Center to Advance Palliative Care website. Available at: www.capc.org/news-and-events/releases/07-14-11. Accessed Aug. 30, 2011.
2. The National Consensus Project’s Clinical Practice Guidelines for Quality Palliative Care. The National Consensus Project website. Available at: www.nationalconsensusproject.org/. Accessed Aug. 31, 2011.

A new Joint Commission program offering advanced certification for hospital-based palliative-care services is accepting applications and conducting daylong surveys through the end of this month. As with the Joint Commission’s reviews of other specialty services (e.g. primary stroke centers), certification is narrower in scope, with service-specific evaluation of care and outcomes, than a full accreditation survey—which is an organizationwide evaluation of core processes and functions.

Advanced certification in palliative care is voluntary for the steadily growing number of acute-care hospitals offering palliative-care services (1,568, according to the latest count by the American Hospital Association), but the hospital seeking it must be accredited by the Joint Commission.1 Certification is intended for formal, defined, inpatient palliative care, whether dedicated units or consultation services, with the ability to direct clinical management of patients.

The core palliative-care team includes “licensed independent practitioners” (typically physicians), registered nurses, chaplains, and social workers.2 The service should follow palliative-care guidelines and evidence-based practice, and it must collect quality data on four performance measures—two of them clinical—and use these data to improve performance.

According to Michelle Sacco, the Joint Commission’s executive director for palliative care, evidence-based practice includes ensuring appropriate transitions to other community resources, such as hospices. She thinks the program is perfect for hospitalists, as HM increasingly is participating in palliative care in their hospitals. “This is also an opportunity to change the mindset that palliative care is for the end-stage only,” Sacco says.

Two-year certification costs $9,655, including the onsite review. For more information, visit the Joint Commission website (www.jointcommission.org/certification) or the Center to Advance Palliative Care’s site (www.capc.org).

References

1. Palliative care in hospitals continues rapid growth for 10th straight year, according to latest analysis. Center to Advance Palliative Care website. Available at: www.capc.org/news-and-events/releases/07-14-11. Accessed Aug. 30, 2011.
2. The National Consensus Project’s Clinical Practice Guidelines for Quality Palliative Care. The National Consensus Project website. Available at: www.nationalconsensusproject.org/. Accessed Aug. 31, 2011.

MIAMI BEACH – Patients with Hodgkin’s lymphoma may be spared additional radiotherapy following chemotherapy if they have a negative positron-emission tomography result, investigators from the German Hodgkin Study Group reported.

The negative predictive value for FDG (¹⁸fluorodeoxyglucose)–PET at 1 year was 94%, said Dr. Rolf P. Mueller of the University of Cologne (Germany). Among patients who had residual tumors measuring 2.5 cm or greater in diameter following chemotherapy, only 4% of those who were negative for residual disease on FDG-PET scans relapsed or required additional radiotherapy, compared with 11% of FDG-PET–positive patients.

"Thus, only those advanced-stage Hodgkin lymphoma patients with residual disease who are PET-positive patients might need additional radiotherapy," Dr. Mueller said at the annual meeting of the American Society of Radiation Oncology (ASTRO).

The investigators also found a significant difference in time-to-progression favoring PET-negative patients (P =.008) with Hodgkin’s lymphoma, also known as Hodgkin’s disease.

The percentage of patients who received radiation in this clinical trial, designated GHSG (German Hodgkin Study Group) HD-15, was 11%, compared with 70% of patients in the group’s GHSG-9 trial, Mueller noted. GHSG-15 studied the role of FDG-PET for evaluating residual disease and relapse risk among patients with advanced-stage Hodgkin’s lymphoma who had undergone six to eight cycles of chemotherapy with the BEACOPP regimen (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) (J. Clin. Oncol. 2003;21:1734-9).

Early results were published in 2008 (Blood 2008;112: 3989-94). In the current report, Mueller presented data on a larger cohort.

All patients with a partial response or better and a residual mass measuring 2.5 cm or greater received FDG-PET scans. Of the 728 patients with residual disease following BEACOPP, 540 (74.2%) were PET negative, and 188 were PET positive. Mueller presented data on 701 patients who had at least 1 year of follow-up.

At 1 year, 96% (522) of PET-negative patients had neither progression nor relapse, compared with 11% of those who were PET positive. Of the PET-negative patients, 23 experienced disease progression (eight in the residual mass, six with new disease outside of the mass, and nine with progression/relapse in both areas). An additional eight PET-negative patients required additional radiotherapy.

The study was funded by the member centers of the GSHG. Dr. Mueller had no conflict of interest disclosures.

MIAMI BEACH – Patients with Hodgkin’s lymphoma may be spared additional radiotherapy following chemotherapy if they have a negative positron-emission tomography result, investigators from the German Hodgkin Study Group reported.

The negative predictive value for FDG (¹⁸fluorodeoxyglucose)–PET at 1 year was 94%, said Dr. Rolf P. Mueller of the University of Cologne (Germany). Among patients who had residual tumors measuring 2.5 cm or greater in diameter following chemotherapy, only 4% of those who were negative for residual disease on FDG-PET scans relapsed or required additional radiotherapy, compared with 11% of FDG-PET–positive patients.

"Thus, only those advanced-stage Hodgkin lymphoma patients with residual disease who are PET-positive patients might need additional radiotherapy," Dr. Mueller said at the annual meeting of the American Society of Radiation Oncology (ASTRO).

The investigators also found a significant difference in time-to-progression favoring PET-negative patients (P =.008) with Hodgkin’s lymphoma, also known as Hodgkin’s disease.

The percentage of patients who received radiation in this clinical trial, designated GHSG (German Hodgkin Study Group) HD-15, was 11%, compared with 70% of patients in the group’s GHSG-9 trial, Mueller noted. GHSG-15 studied the role of FDG-PET for evaluating residual disease and relapse risk among patients with advanced-stage Hodgkin’s lymphoma who had undergone six to eight cycles of chemotherapy with the BEACOPP regimen (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) (J. Clin. Oncol. 2003;21:1734-9).

Early results were published in 2008 (Blood 2008;112: 3989-94). In the current report, Mueller presented data on a larger cohort.

All patients with a partial response or better and a residual mass measuring 2.5 cm or greater received FDG-PET scans. Of the 728 patients with residual disease following BEACOPP, 540 (74.2%) were PET negative, and 188 were PET positive. Mueller presented data on 701 patients who had at least 1 year of follow-up.

At 1 year, 96% (522) of PET-negative patients had neither progression nor relapse, compared with 11% of those who were PET positive. Of the PET-negative patients, 23 experienced disease progression (eight in the residual mass, six with new disease outside of the mass, and nine with progression/relapse in both areas). An additional eight PET-negative patients required additional radiotherapy.

The study was funded by the member centers of the GSHG. Dr. Mueller had no conflict of interest disclosures.

MIAMI BEACH – Patients with Hodgkin’s lymphoma may be spared additional radiotherapy following chemotherapy if they have a negative positron-emission tomography result, investigators from the German Hodgkin Study Group reported.

The negative predictive value for FDG (¹⁸fluorodeoxyglucose)–PET at 1 year was 94%, said Dr. Rolf P. Mueller of the University of Cologne (Germany). Among patients who had residual tumors measuring 2.5 cm or greater in diameter following chemotherapy, only 4% of those who were negative for residual disease on FDG-PET scans relapsed or required additional radiotherapy, compared with 11% of FDG-PET–positive patients.

"Thus, only those advanced-stage Hodgkin lymphoma patients with residual disease who are PET-positive patients might need additional radiotherapy," Dr. Mueller said at the annual meeting of the American Society of Radiation Oncology (ASTRO).

The investigators also found a significant difference in time-to-progression favoring PET-negative patients (P =.008) with Hodgkin’s lymphoma, also known as Hodgkin’s disease.

The percentage of patients who received radiation in this clinical trial, designated GHSG (German Hodgkin Study Group) HD-15, was 11%, compared with 70% of patients in the group’s GHSG-9 trial, Mueller noted. GHSG-15 studied the role of FDG-PET for evaluating residual disease and relapse risk among patients with advanced-stage Hodgkin’s lymphoma who had undergone six to eight cycles of chemotherapy with the BEACOPP regimen (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) (J. Clin. Oncol. 2003;21:1734-9).

Early results were published in 2008 (Blood 2008;112: 3989-94). In the current report, Mueller presented data on a larger cohort.

All patients with a partial response or better and a residual mass measuring 2.5 cm or greater received FDG-PET scans. Of the 728 patients with residual disease following BEACOPP, 540 (74.2%) were PET negative, and 188 were PET positive. Mueller presented data on 701 patients who had at least 1 year of follow-up.

At 1 year, 96% (522) of PET-negative patients had neither progression nor relapse, compared with 11% of those who were PET positive. Of the PET-negative patients, 23 experienced disease progression (eight in the residual mass, six with new disease outside of the mass, and nine with progression/relapse in both areas). An additional eight PET-negative patients required additional radiotherapy.

The study was funded by the member centers of the GSHG. Dr. Mueller had no conflict of interest disclosures.